Multipolar Mapping and Atrial Arrhythmias
Atrial Signal Analysis Using a Multipolar Catheter in Patients Undergoing Atrial Fibrillation and Flutter Ablations
1 other identifier
interventional
5
1 country
1
Brief Summary
This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the left and right atria to explore atrial signal characteristics that can guide atrial fibrillation and atrial flutter ablation procedures more effectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 25, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
March 16, 2016
CompletedMarch 16, 2016
February 1, 2016
1.1 years
November 25, 2014
December 4, 2015
February 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Atrial Fibrillation Dominant Frequency
Electrogram signal analysis will be performed to assess the dominant frequency of the atrial fibrillation electrograms collected by this catheter. These values will be correlated to patient outcomes.
1 year
Study Arms (1)
Basket Catheter
EXPERIMENTALThe Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.
Interventions
64-electrode intracardiac mapping catheter.
Eligibility Criteria
You may qualify if:
- Patients referred to the PI (Dr. Biviano) or co-investigators in the Program of Cardiac Electrophysiology at Columbia University Medical Center who are scheduled to undergo ablation will be approached for recruitment:
- Older than 45 years of age
- History of AF and/or AFL and are candidates for catheter ablation.
You may not qualify if:
- Patients not fitting the above clinical criteria or unwilling to comply with the instructions of the monitor are excluded, as well as patients with the following:
- Permanent leads or prosthetic or stenotic valves present
- Active systemic infection
- Echocardiographically-confirmed visual presence of thrombus
- For whom the inability of obtaining vascular access exists
- Heparin-induced thrombocytopenia
- Hemodynamic instability or shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Angelo Bivianolead
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Abgelo Biviano
- Organization
- Columbia University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Angelo B Biviano, MD, MPH
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
November 25, 2014
First Posted
December 4, 2014
Study Start
November 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 16, 2016
Results First Posted
March 16, 2016
Record last verified: 2016-02